10 September, 2014- In a move towards furthering access to affordable medicines, Lawyers Collective through Sankalp Rehabilitation Trust, the Hepatitis Coalition of Nagaland and Network of PLHIV living in the Asia Pacific region (APN+), filed a pre- grant challenge to sofosbuvir (Sovaldi) inIndia. The opposition is against the pro-drug patent application 3658/kolnp/2009 which is awaiting examination before the Controller of Patents, Kolkata.

Sofosbuvir, produced by Gilead, is the first oral daily tablet for hepatitis C which is set to revolutionize treatment for patients living with chronic Hepatitis C by replacing the standard, therapy of weekly injections of peg- interferon which can have serious side-effects. However, the cost of the Sofosbuvir in the United States is as much as $84,000 per patient per treatment! Preliminary reports suggest that Gilead is negotiating licenses with generic companies in India at $ 900 per treatment per patient. If the patent is not granted, however, the price could be reduced further that could lead to millions of lives being saved.

Lawyers Collective has consistently filed patent oppositions on key drugs on behalf of the community. Such oppositions can be filed before and after the patent is granted.

The main grounds of challenge in the present opposition is that Sofosbuvir lacks novelty, inventive step and does not fulfill the requirement of section 3(d) of the Patents Act, 1970. The patent controller is now expected to hear the opponents and the patent should be granted or not

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